title: The Mosaic bioprosthesis in the aortic position: 17 years' results.
abstract: BACKGROUND
  The Mosaic bioprosthesis (Medtronic Inc., Minneapolis, Minnesota, United States), a stented porcine aortic valve, combines glutaraldehyde fixation with zero-pressure, root-pressure techniques and antimineralization treatment with amino-oleic acid for improved hemodynamics and tissue durability. The first device has been implanted worldwide at the authors' institution in September 1993. The aim of the present study was to collect mid- to long-term data of the prosthesis.
  
  
  METHODS
  A total of 272 patients (124 males and 148 females) underwent isolated aortic valve replacement with the Mosaic bioprosthesis between September 1993 and August 2007. Median age at implant was 76.8 years (range, 31.3 to 90.7). Median follow-up was 12.0 years (range, 0 to 17.2 years); follow-up was complete for 223 (82%) patients.
  
  
  RESULTS
  Early mortality (30 days) was 4% (12 patients). Overall survival at 5, 10, 15, and 17 years was 68.6% ± 3.1%, 36.4% ± 3.3%, 17.1% ± 3.6%, and 10.7% ± 4.3%, respectively. Eleven late deaths (5%) were cardiac related. There were 24 thromboembolic events, 1 hemorrhagic, and 6 reoperations/explants. At a median follow-up of 12 years, freedom from any cause of death was 27.0% ± 3.2% acting as a competing risk for the incidence of thromboembolic events (16.4% ± 3.5%), hemorrhage (0.5% ± 0.5%), and reoperation/explant (4.1% ± 1.8%). Two redos were due to structural valve deterioration (SVD), two for nonstructural dysfunction (paravalvular leakage), one for thrombosed prosthesis, and one for endocarditis.
  
  
  CONCLUSIONS
  Performance and late outcome of the Mosaic bioprosthesis was satisfactory during 17 years after clinical introduction. The Mosaic bioprosthesis showed low incidence of SVD or need for reoperation in the long term.
authors.affiliation: Department of Cardiovascular Surgery, Clinic Bogenhausen, Munich, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Gansera
authors.affiliation: Institute of Medical Statistics and Epidemiology, Technical University Munich, Munich, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Hapfelmeier
authors.affiliation: Department of Cardiovascular Surgery, Clinic Bogenhausen, Munich, Germany.
authors.forename: Kristina
authors.initials: K
authors.lastname: Brandl
authors.affiliation: Department of Cardiovascular Surgery, Clinic Bogenhausen, Munich, Germany.
authors.forename: Kyriakos
authors.initials: K
authors.lastname: Spiliopoulos
authors.affiliation: Department of Cardiovascular Surgery, Clinic Bogenhausen, Munich, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Gundling
authors.affiliation: Department of Cardiovascular Surgery, Clinic Bogenhausen, Munich, Germany.
authors.forename: Walter
authors.initials: W
authors.lastname: Eichinger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality / Q000601:surgery; D011474:Prosthesis Design; D012086:Reoperation; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome